BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMA HIP

    MDR report key: 2631634 · Received June 21, 2012

    Report

    Report Number
    1644408-2012-00322
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DJO SURGICAL RECEIVED THIS COMPLAINT OF A REPORTABLE EVENT AND HAS DETERMINED THAT THE MANUFACTURE OF THE DEVICE IN QUESTION WAS OSTEOIMPLANT TECHNOLOGIES, INC. (OTI) NOW KNOWN AS PINNACLE HOLDING INC. AS PART OF ENCORE MEDICAL'S ACQUISITION OF THE OTI PRODUCT LINES, OTI AGREED TO ASSUME ALL REGULATORY RESPONSIBILITIES FOR PRODUCT IMPLANTED PRIOR TO ENCORE'S ACQUISITION OF THEIR PRODUCT LINES ON FEBRUARY 22, 2005. (B)(6).

    Description of Event or Problem · 1

    REVISION SURGERY/INSTRUMENT FAILURE - THE ALLEN WRENCH STRIPPED DURING SURGERY. THE INSTRUMENT FAILURE LED TO A 45 MINUTE DELAY AS OTHER INSTRUMENTATION HAD TO BE USED TO CUT INTO THE SCREW TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMA HIP ALLEN WRENCH HXC ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention